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Wipro GE Healthcare Private Ltd.

FDA Regulatory Profile

Summary

Total Recalls
10 (6 Class I)
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0213-2026Class IIGE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part September 5, 2025
Z-0214-2026Class IIGE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part September 5, 2025
Z-3080-2024Class IIGE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared hAugust 9, 2024
Z-3081-2024Class IIGE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) MAugust 9, 2024
Z-0961-2024Class IGE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M120December 26, 2023
Z-0957-2024Class IGE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000,December 26, 2023
Z-0962-2024Class IGE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512December 26, 2023
Z-0959-2024Class IGE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-00December 26, 2023
Z-0958-2024Class IGE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) LDecember 26, 2023
Z-0960-2024Class IGE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800December 26, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K1236811.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COILFebruary 22, 2013
K121625LULLABY TM WARMERSeptember 14, 2012
K120168LULLABY LED PHOTTHERAPY SYSTEMMay 2, 2012
K110556MINI TELEMETRY SYSTEMJuly 19, 2011
K102104GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMOctober 1, 2010